BVI® is a global ophthalmic medical device manufacturer (headquarter Waltham, Massachusetts, US) with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. The business has been built on developing leading products and brands in each product segment that the business operates. BVI® supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.
For its innovation unit (PhysIOL Intraocular Lenses) located in the Liège Science Park (Belgium), BVI mandated Profile Group for the recruitment of their future QMS Specialist, to help them realize their ambitions.
You manage the quality system for compliance and effectiveness:
- You’re responsible for document/data control
- You participate to QMS processes improvement
- You coordinate and perform projects including system validation and documents/data processes improvement
- You coordinate any new eQMS implementation into the organization
- You ensure compliance of the eQMS with internal activities and ISO 13485 requirements
- You perform audits as lead auditor and manage external audits
- You participate in implementation of global systems and validation thereof
You can assume additional functions which will be created further to new procedures:
- To maintains the documents for his/her activities
- To collect, analyze and prepare information for Managements Reviews/ KPIs and all other activities which need to highlight into his/her activities.
Key words : software, automation, QMS, eQMS, Vivaldi, quality, qualité, validation, quality system, document control, data control, system validation
- You have a Master’s degree or Engineering and 5 years or more experience in quality
- You have a good knowledge of ISO13485, ISO 9001, MDD, MDR and MDSAP requirements in link with QMS activities
- You’re fluent in English
- You use Vivaldi (internal eQMS) / eQMS system
- You use of quality tools
- You have an methodical approach, an problem-solving skills
- You have an initiative, organizational skills and critical thinking
You are joining a dynamic & fast-growing environment at the cutting edge of technology and innovation in a global company with great human values, which encourages its teams to take initiatives that contribute to its success.
Profile Group manages this mission in exclusivity. Any interested candidate is therefore invited to apply exclusively through this ad (apply now) or by contacting Profile Group directly. contact: Anaelle Henrard – email@example.com – 0470/40.77.30
Call ANAELLE HENRARD
at the number: 0470 40 77 30